AxoGen Inc (AXGN) 2024 Q3 法說會逐字稿

Good morning, everyone. Joining me on today's call is Michael Dale, Axogen's Chief Executive Officer and Director; and Nir Naor, Chief Financial Officer. Michael will discuss third quarter 2024 financial results, and Nir will provide an analysis of our financial performance and guidance and discuss our outlook for the year, followed by a question-and-answer session.

大家早安。參加今天電話會議的是 Axogen 執行長兼董事 Michael Dale；首席財務官 Nir ​​Naor。Michael 將討論 2024 年第三季的財務業績，Nir 將提供我們的財務業績和指導分析，並討論我們對今年的展望，然後進行問答環節。

Today's call is being broadcast live via webcast, which is available on the Investors section of Axogen's website. Following the end of the live call, a replay will be available in the Investors section of the company's website at www.axogeninc.com.

今天的電話會議透過網路直播進行現場直播，可在 Axogen 網站的投資者部分觀看。現場電話會議結束後，公司網站 www.axogeninc.com 的投資者部分將提供重播。

Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements. Forward-looking statements include, but are not limited to, all statements relating to financial guidance, including revenue, margins, cash flow and future profitability, the availability to fund ongoing operations, the availability to expand markets and revenue, expectations for growth, marketing opportunities within existing and new nerve repair markets and applications and the expected approval of the biologic license application for Avance Nerve Graft, including the anticipated approval time line, the assumption that Avance Nerve Graft will be designated as a reference product for any future biosimilar nerve graft and that such designation will provide marketplace exclusivity.

在我們開始之前，我想提醒您，在本次電話會議期間，公司將做出預測和前瞻性陳述。前瞻性陳述包括但不限於與財務指導相關的所有陳述，包括收入、利潤、現金流量和未來盈利能力、為持續運營提​​供資金的可用性、擴大市場和收入的可用性、增長預期、營銷現有和新的神經修復市場和應用中的機會，以及Avance 神經移植生物許可證申請的預期批准，包括預期的批准時間線，假設Avance 神經移植將被指定為任何未來生物仿製藥神經移植的參考產品並且這種指定將提供市場排他性。

Forward-looking statements are based on current beliefs and assumptions and are not guarantees of future performance and are subject to risks and uncertainties, including, without limitation, the risks and uncertainties reflected in the company's annual and periodic reports, such as hospital staffing issues, regulatory process and approvals, surgeon and product adoption and market awareness of our products.

前瞻性陳述基於當前的信念和假設，並非對未來業績的保證，並受到風險和不確定性的影響，包括但不限於公司年度和定期報告中反映的風險和不確定性，例如醫院人員配置問題、監管流程和批准、外科醫生和產品的採用以及我們產品的市場認知度。

The forward-looking statements are representative only as of the date they are made, and except as required by applicable law, the company assumes no responsibility to publicly update or revise any forward-looking statements.

前瞻性陳述僅具有截至發布之日的代表性，除非適用法律要求，否則本公司不承擔公開更新或修改任何前瞻性陳述的責任。

In addition, for a reconciliation of non-GAAP measures, please refer to today's press release and the corporate presentation on the Investors section of the company's website.

此外，有關非公認會計原則措施的調節，請參閱今天的新聞稿以及公司網站投資者部分的公司介紹。

Now I'll turn the call over to Michael.

現在我將把電話轉給麥可。

Thanks, operator, and thanks, everyone, for joining us today. I'll begin our call by providing a brief overview of our third quarter performance. Then since this is my first call as the CEO of Axogen, I'd like to take time to address a few of the more common questions I get as Axogen's new leader, what compelled me to join Axogen, what have I been doing since joining the business in August and what are our plans for the business going forward. Following this, I will also provide some additional color on our quarterly performance, after which Nir will provide a review of our financial results, followed by a question and answer.

謝謝操作員，也謝謝大家今天加入我們。在我們的電話會議開始時，我將簡要概述我們第三季的業績。然後，由於這是我作為Axogen 首席執行官的第一次電話會議，我想花時間回答一些作為Axogen 新領導者時遇到的更常見的問題，是什麼促使我加入Axogen，自從加入以來我一直在做什麼八月份的業務以及我們未來的業務計劃是什麼。接下來，我還將對我們的季度業績提供一些額外的信息，之後尼爾將對我們的財務業績進行審查，然後進行問答。

So let's begin. We are pleased with the quarter's top line revenue and EBITDA growth. Revenue was $48.6 million, an increase of approximately 18% compared to last year, while adjusted EBITDA was $6.5 million versus $2.4 million last year. Notably, revenue performance in the quarter was broad-based, reflecting growth across our portfolio. Both revenue and EBITDA were positively impacted by improved sales productivity and commercial execution of our present growth strategy.

那麼就讓我們開始吧。我們對本季的營收和 EBITDA 成長感到滿意。營收為 4,860 萬美元，比去年成長約 18%，調整後 EBITDA 為 650 萬美元，而去年為 240 萬美元。值得注意的是，本季的營收表現基礎廣泛，反映了我們整個投資組合的成長。我們目前成長策略的銷售生產力和商業執行的提高對收入和 EBITDA 產生了積極影響。

Regarding the most common questions I am asked, I'll begin with why Axogen. Very simply, Axogen as a business opportunity, fulfills all 3 of the most important elements required for success in my estimation. Firstly, the purpose of the business is credible and relevant. Secondly, the clinical problem is numerous enough to justify the allocation of time, capital and people to build a business. And finally, there is clear and compelling evidence the solution to the business purpose is distinctively advantaged relative to the existing standards of care. Everything I've observed and experienced since joining the organization reaffirms this estimation.

關於我被問到的最常見問題，我將從為什麼選擇 Axogen 開始。很簡單，Axogen 作為一個商業機會，滿足了我認為成功所需的所有 3 個最重要的要素。首先，業務目的可信且相關。其次，臨床問題數量眾多，足以證明分配時間、資金和人員建立企業是合理的。最後，有明確且令人信服的證據表明，該商業目的的解決方案相對於現有的護理標準具有明顯的優勢。自從加入組織以來，我所觀察和經歷的一切都再次證實了這個估計。

While our future is obviously dependent upon execution of our future plan across business functions, these are mechanics I understand and have confidence in how to apply by function. I learned many years ago, however, that good mechanics can't overcome an irrelevant purpose or undifferentiated product solutions.

雖然我們的未來顯然取決於跨業務職能的未來計劃的執行，但這些是我理解的機制，並且對如何按職能應用有信心。然而，我多年前就了解到，好的機制無法克服不相關的目的或無差異化的產品解決方案。

I've had the privilege to test this thesis on numerous occasions over the last 30-plus years in both public and private companies, leading and bringing to market numerous transformative products and therapies in the cardiovascular, neuromodulation, diabetes and electrophysiology markets. I love what I do, which is why I'm still doing it, and I believe Axogen is a very important business with significant undeveloped potential.

在過去 30 多年裡，我有幸在上市公司和私人公司多次驗證了這篇論文，在心血管、神經調節、糖尿病和電生理學市場上領導並向市場推出了許多變革性產品和療法。我熱愛我所做的事情，這就是我仍然這樣做的原因，我相信 Axogen 是一項非常重要的業務，具有巨大的未開發潛力。

As for the remaining 2 questions, what have I been doing since joining the company and what is the plan for the business going forward, on day 1, we established 3 priorities for the remainder of the year: number one, successfully complete the submission of our BLA application; number two, meet our established revenue guidance for the year; and lastly, develop a new strategic operating plan for the business, engaging all employees and key external stakeholders in the process.

至於剩下的2個問題，自從加入公司以來我一直在做什麼以及未來的業務計劃是什麼，在第一天，我們為今年剩餘時間確定了3個優先事項：第一，成功完成提交我們的BLA 申請；第二，滿足我們既定的今年收入指導；最後，為企業制定新的策略營運計劃，讓所有員工和主要外部利害關係人參與此過程。

Consistent with the purpose of strategic planning and relative to the mission underlying our business purpose, our aim is understanding what are the necessary objectives, strategies and processes required to achieve standard of care status for the company's products by market opportunity.

與策略規劃的目的一致，並相對於我們業務目標的使命，我們的目標是了解透過市場機會實現公司產品護理狀態標準所需的必要目標、策略和流程。

While we have one primary product, Avance, upon which the business was founded, the respective applications for Avance are numerous and constitute, in many instances, distinctly different market opportunities characterized by different physician call points and requiring, therefore, different business models.

雖然我們有一個主要產品Avance，該業務是在該產品上建立的，但Avance 的相應應用程序數量眾多，並且在許多情況下構成了截然不同的市場機會，其特點是不同的醫生呼叫點，因此需要不同的商業模式。

How we prioritize the development of these different opportunities based on return on time and ability to impact standard of care are critical choices. To answer, therefore, the last question, I look forward to providing details on our strategic plan on our fourth quarter call in early 2025, at which time we will describe in detail what we believe will be the most attractive market opportunities for the business and the required business models and time lines for their development.

我們如何根據時間回報和影響護理標準的能力來優先開發這些不同的機會是關鍵的選擇。因此，為了回答最後一個問題，我期待在 2025 年初的第四季度電話會議上提供有關我們戰略計劃的詳細信息，屆時我們將詳細描述我們認為對企業來說最具吸引力的市場機會，以及其發展所需的商業模式和時間表。

Returning to our quarterly results. As described in our earnings release, overall, we had a solid quarter, achieving several major milestones. We are pleased with the positive trends in revenue growth, bottom line performance and, importantly, the completion of the rolling submission process and the acceptance by the FDA of the filing of the BLA for Avance Nerve Graft.

回到我們的季度業績。正如我們的財報中所述，總體而言，我們度過了一個穩定的季度，實現了幾個重大里程碑。我們對收入成長、獲利表現的正面趨勢感到高興，更重要的是，滾動提交流程的完成以及 FDA 接受 Avance 神經移植 BLA 的提交。

Our strategy remains focused on deepening our presence in high potential accounts, which are primarily characterized by the following criteria: larger hospitals, including Level 1 trauma centers and/or academic affiliated hospitals with a high number of nerve repair procedures; and lastly, already trained microsurgeons.

我們的策略仍然專注於深化我們在高潛力客戶中的存在，這些客戶主要具有以下標準：較大的醫院，包括擁有大量神經修復手術的一級創傷中心和/或學術附屬醫院；最後，已經接受過訓練的顯微外科醫生。

We aim to drive growth in these types of accounts through targeted expansion of nerve repair indications by building on the existing experience in nerve repair in the account, the inherent potential of the account to grow based on size and procedure volume and expanding adoption of our nerve repair algorithm to other surgical specialties within these accounts. We believe our focus on these high potential accounts is the reason for our recent improvements in sales productivity in our extremities trauma and head and neck business, in particular.

我們的目標是透過有針對性地擴大神經修復適應症，透過利用帳戶中神經修復的現有經驗、帳戶根據規模和手術量增長的內在潛力以及擴大神經修復的採用來推動此類帳戶的增長修復這些帳戶中其他外科專業的演算法。我們相信，我們對這些高潛力客戶的關注是我們最近提高四肢創傷和頭頸業務銷售效率的原因。

Regarding revenue mix, we saw broad-based growth across the portfolio, including an increase in nerve reconstruction cases in our targeted clinical applications such as upper extremity trauma, mandible reconstruction and breast neurotization as well as growth from nerve protection procedures.

在收入組合方面，我們看到整個投資組合的廣泛增長，包括我們的目標臨床應用中神經重建病例的增加，例如上肢創傷、下顎骨重建和乳房神經化，以及神經保護手術的增長。

Our growth in nerve protection is driven by adoption of our newest solutions, AxoGuard, HA, Nerve Protector and Avive+ Soft Tissue Matrix, which gives Axogen the most comprehensive portfolio to address these common non-transected nerve injuries.

我們在神經保護領域的成長得益於我們最新解決方案 AxoGuard、HA、Nerve Protector 和 Avive+ 軟組織基質的採用，這為 Axogen 提供了最全面的產品組合來解決這些常見的非橫斷神經損傷。

Other key events and programs during the quarter include our continued commitment to leadership in professional education. During the quarter, we sponsored a National Resensation Breast Program as well as numerous regional surgeon education programs in extremities and head and neck. These programs are a key driver of new surgeon activation and broader adoption of our nerve repair portfolio.

本季的其他重要活動和計劃包括我們繼續致力於在專業教育領域發揮領導作用。在本季度，我們贊助了一項全國乳房感知計劃以及眾多四肢和頭頸區域外科醫生教育計劃。這些計劃是新外科醫生激活和更廣泛採用我們的神經修復產品組合的關鍵驅動力。

In Q3, we also attended the American Society for Surgery of the Hand in Minneapolis. Nerve was an important topic at this meeting, and we continue to see a growing interest in incorporating nerve repair among the hand surgeon community. This year, we presented novel data on the extent of nerve damage that occurs in common injuries, the importance of protection of the nerve coaptation site and the growing role of Avance Nerve Graft in sensory, mixed and motor nerve repair.

第三季度，我們也參加了在明尼阿波利斯舉行的美國手外科學會。神經是本次會議的重要議題，我們繼續看到手外科醫生界對神經修復的興趣日益濃厚。今年，我們提供了關於常見損傷中神經損傷程度、保護神經接合部位的重要性以及 Avance 神經移植在感覺、混合和運動神經修復中日益增長的作用的新數據。

The data presented characterized the extent of nerve damage from common trauma injuries and was generated in collaboration with a leading group of hand surgeons. This involved quantifying the extent of damage from common traumas using micro-CT and other advanced imaging modalities.

所提供的數據描述了常見外傷造成的神經損傷程度，是與領先的手部外科醫生團隊合作產生的。這涉及使用微型 CT 和其他先進的成像方式來量化常見創傷的損傷程度。

Importantly, these findings will help further the understanding of how these common traumatic lacerations lead to a more extensive zone of injury than previously appreciated as compared to a surgeon's traditional methods of visual estimation.

重要的是，這些發現將有助於進一步了解這些常見的創傷性撕裂傷如何導致比以前認為的更廣泛的損傷區域，與外科醫生傳統的視覺估計方法相比。

We also saw a presentation of data from a recently published med analysis comparing meaningful recovery rates of suture-only direct repair to connector-assisted repair. The study findings reported significantly greater proportion of patients achieving meaningful recovery and higher levels of meaningful recovery when connector-assisted repair was performed compared to suture-only direct repair. These data and publications highlight the growing understanding of nerve injury and the important role our products play in nerve repair.

我們還看到了最近發表的一項醫學分析數據的介紹，該分析比較了僅縫合直接修復與連接器輔助修復的有意義的恢復率。研究結果表明，與僅縫合的直接修復相比，進行連接器輔助修復時，實現有意義康復的患者比例顯著更高，並且有意義的恢復水平更高。這些數據和出版物凸顯了人們對神經損傷的日益深入的了解以及我們的產品在神經修復中的重要作用。

Turning to the BLA for Avance Nerve Graft. In September, we completed the rolling submission process. On November 1, we were informed by the FDA that they have completed our filing review and have determined our application is sufficiently complete to permit a substantive review, which allows for a time line and approval with a review goal date of September 5, 2025. Additionally, they informed us that they are not currently planning to hold an Advisory Committee meeting.

轉向 Avance 神經移植的 BLA。九月，我們完成了滾動提交流程。11 月1 日，FDA 通知我們，他們已經完成了我們的備案審查，並確定我們的申請足夠完整，可以進行實質性審查，從而確定了時間表和批准時間，審查目標日期為2025 年9 月5日。此外，他們也告訴我們，他們目前不打算舉行諮詢委員會會議。

As a reminder, a BLA approval will complete the regulatory process to transition Avance Nerve Graft to a 351 biological product. Importantly, we believe Avance will be designated as a reference product for potential biosimilars, providing at least 12 years of market exclusivity from the approval date.

提醒一下，BLA 的批准將完成將 Avance 神經移植物轉變為 351 生物產品的監管流程。重要的是，我們相信 Avance 將被指定為潛在生物相似藥的參考產品，並從批准之日起提供至少 12 年的市場獨佔權。

In conclusion, we are pleased with our third quarter results, which reflect the successful execution of our current growth strategy and commitments to science-based education and market development. Looking ahead, we remain focused on completing the BLA application process, meeting our revenue guidance for the year and completing our new strategic operating plan.

總之，我們對第三季的業績感到滿意，這反映了我們當前成長策略的成功執行以及對科學教育和市場開發的承諾。展望未來，我們仍然專注於完成 BLA 申請流程、滿足我們今年的收入指導並完成我們新的策略營運計劃。

I will now hand over the call to Nir, who will provide further details on our financials and full year guidance. Nir?

我現在將把電話轉交給 Nir，他將提供有關我們財務狀況和全年指導的更多詳細資訊。尼爾？

Thank you, Mike. We're excited about our results for this quarter. We have seen a lot of progress in our strategy, and our commercial execution continues to yield solid results.

謝謝你，麥克。我們對本季的業績感到興奮。我們的策略取得了很大進展，我們的商業執行也持續取得紮實的成果。

Turning to our financials. For this quarter, our revenue was $48.6 million, representing 17.9% growth from the third quarter of 2023. This growth is attributed to a 13.7% increase in unit volume and mix and a 4.2% increase in price. Higher unit volumes were driven by broad strength across the existing product portfolio and momentum from new product introductions.

轉向我們的財務狀況。本季度，我們的營收為 4,860 萬美元，較 2023 年第三季成長 17.9%。這一增長歸因於單位數量和產品組合增加 13.7%，以及價格上漲 4.2%。現有產品組合的廣泛實力和新產品推出的動力推動了銷售量的增加。

Our gross profit for the quarter was $36.4 million, an increase from the $31.7 million recorded in the third quarter of 2023. This represents gross margin of 74.9%, down from 76.8% in the same period last year, driven by product mix.

我們本季的毛利為 3,640 萬美元，較 2023 年第三季的 3,170 萬美元有所增加。受產品結構影響，毛利率為 74.9%，低於去年同期的 76.8%。

Notably, we saw a sequential increase from the prior quarter gross profit margin of 73.8%, sorry, as we continue to make improvements in our operating processes at the APC facility.

值得注意的是，我們看到毛利率比上一季的 73.8% 有所增長，抱歉，因為我們繼續改進 APC 工廠的營運流程。

Our total operating expenses for the quarter increased by 2.9% to $36.8 million, up from $35.7 million in Q3 of 2023.

我們本季的總營運費用成長 2.9%，達到 3,680 萬美元，高於 2023 年第三季的 3,570 萬美元。

Our sales and marketing expenses for the third quarter decreased by 1.3% to $18.9 million, partly driven by the Avance royalty fee, which we ceased paying as of the end of last year. As a percentage of total revenue, our sales and marketing expenses for the third quarter decreased to 38.9% from 46.4% in the third quarter of 2023, also reflecting improved sales force productivity.

我們第三季的銷售和行銷費用下降了 1.3%，至 1,890 萬美元，部分原因是我們從去年年底開始停止支付 Avance 特許權使用費。我們第三季的銷售和行銷費用佔總收入的百分比從 2023 年第三季的 46.4% 下降至 38.9%，也反映出銷售人員生產力的提高。

Research and development expenses increased by 4.5% to $7 million from $6.7 million in the third quarter of 2023. As a percentage of total revenues, total R&D expenses decreased to 14.4% from 16.2% in the same quarter of the previous year.

研發費用從 2023 年第三季的 670 萬美元增加到 700 萬美元，成長 4.5%。總研發費用佔總收入的比例從去年同期的16.2%下降至14.4%。

General and administrative expenses increased by 9.8% to $10.8 million in the third quarter of 2024 compared to $9.9 million in the same quarter of 2023, driven by stock-based compensation expense related to the departure of the former CEO.

2024 年第三季的一般和管理費用成長 9.8%，達到 1,080 萬美元，而 2023 年同一季度為 990 萬美元，受前執行長離職相關的股票薪酬費用的推動。

The quarter ended with a net loss of $1.9 million or $0.04 per share compared to a net loss of $4.1 million or $0.10 per share in the third quarter of 2023.

本季末淨虧損為 190 萬美元，即每股 0.04 美元，而 2023 年第三季的淨虧損為 410 萬美元，即每股 0.10 美元。

Adjusted net income was $3.1 million for the quarter or $0.07 per share compared to an adjusted net income of $0.7 million or $0.01 per share in the same period last year.

本季調整後淨利為 310 萬美元，即每股 0.07 美元，而去年同期調整後淨利為 70 萬美元，即每股 0.01 美元。

Adjusted third quarter EBITDA was $6.5 million compared to an adjusted EBITDA of $2.4 million in the prior year.

第三季調整後 EBITDA 為 650 萬美元，而上年調整後 EBITDA 為 240 萬美元。

Lastly, we generated positive cash flow in the third quarter. As of September 30, our balance of cash, cash equivalents and investments was $30.5 million compared to $27.1 million at the end of the second quarter of 2024.

最後，我們在第三季產生了正現金流。截至 9 月 30 日，我們的現金、現金等價物和投資餘額為 3,050 萬美元，而 2024 年第二季末為 2,710 萬美元。

These improvements in our bottom line profitability metrics, such as adjusted EBITDA and cash flow, reflect our ongoing efforts to focus to improve our operational efficiencies across the organization and our ability to leverage economies of scale. We believe these improvements will enable us to fund our ongoing operations.

我們的底線獲利指標（例如調整後的 EBITDA 和現金流）的這些改進反映了我們持續努力專注於提高整個組織的營運效率以及我們利用規模經濟的能力。我們相信這些改進將使我們能夠為我們的持續營運提供資金。

Turning now to our guidance. As outlined in today's press release, we are maintaining our revenue guidance for the full year 2024 in the range of $182 million to $186 million. We're pleased with our performance year-to-date and are optimistic going into 2025.

現在轉向我們的指導。正如今天的新聞稿所述，我們將 2024 年全年收入指引維持在 1.82 億美元至 1.86 億美元之間。我們對今年迄今的表現感到滿意，並對 2025 年充滿樂觀。

With regards to our full year gross margin guidance, we now expect to be at the high end of the 74% to 76% range we provided earlier. Additionally, we're reaffirming that we expect to be net cash flow positive cumulatively for the period from April 1 through year-end.

關於我們的全年毛利率指導，我們現在預計將處於我們之前提供的 74% 至 76% 範圍的高端。此外，我們重申，我們預計從 4 月 1 日到年底期間累積淨現金流量將為正值。

In summary, we're pleased with our performance in the third quarter. We will continue to execute our strategies, invest in innovation, drive revenue growth and optimize resource allocation and focus on profitability.

總而言之，我們對第三季的表現感到滿意。我們將繼續執行我們的策略，投資創新，推動收入成長，優化資源配置，並專注於獲利能力。

At this time, we'd like to open the line for questions. Operator?

此時，我們想開通提問專線。操作員？

(Operator Instructions)

（操作員說明）

Chris Pasquale with Nephron Research.

克里斯‧帕斯誇萊 (Chris Pasquale)，來自 Nephron 研究中心。

Congrats on the new position, Mike. Wanted to ask about the decision to just reiterate the full year guide, considering that the third quarter performance came in above the implied second half growth rate. And now what's left for the fourth quarter is a pretty wide range and certainly below the recent performance of the company.

恭喜你獲得新職位，麥克。考慮到第三季的業績高於隱含的下半年成長率，我想詢問是否決定重申全年指南。現在第四季剩下的資金範圍相當廣泛，肯定低於公司最近的業績。

So just anything you could tell us about the outlook there and whether there's something that's informing that or it's just conservatism?

那麼，您能告訴我們有關那裡前景的任何信息嗎？

No, fair question. As I've mentioned in my remarks, when I joined the business and started to get to know the team, the most important thing we believed was to demonstrate our ability to forecast predictably and to meet the public guidance, which we had already established.

不，公平的問題。正如我在演講中提到的，當我加入該公司並開始了解團隊時，我們認為最重要的事情是證明我們有能力進行可預測的預測並滿足我們已經建立的公眾指導。

And so that's the commitment that we want to make to all of our stakeholders and as such, why we have not made any adjustments to guidance. So we believe that demonstrating that predictability through the end of the year while we work on our plans for the future was one of the most important things that we could do for folks in the near term, in addition to the other priorities of BLA and just completing that plan.

這就是我們想要向所有利害關係人做出的承諾，因此，我們沒有對指導進行任何調整。因此，我們相信，除了 BLA 的其他優先事項之外，在我們制定未來計劃的同時，在年底前展示這種可預測性是我們近期可以為人們做的最重要的事情之一。

Makes sense. And then I know you're still in the process of formulating the strategic plan, but I think one of the things that has surprised us about the story is the lack of standard of care status of the products given the differentiated clinical outcomes that have been, I think, well demonstrated at this point.

有道理。然後我知道你們仍在製定戰略計劃的過程中，但我認為這個故事讓我們感到驚訝的一件事是，考慮到不同的臨床結果，產品缺乏標準的護理狀態我認為，在這一點上得到了很好的體現。

In your initial review of kind of where the company stands today, do you think you've identified areas that can be improved on in terms of really pushing towards that standard of care status for products like Avance?

在您對公司目前狀況的初步審查中，您是否認為您已經確定了可以改進的領域，以真正推動 Avance 等產品的護理狀態標準？

Yes. Great question and, frankly, one of the most important questions because it goes -- it's central to what is the opportunity for all stakeholders here. And as you described, Avance, in particular, as well as the entire algorithm deserves to be standard of care. But standard of care with any health care product has a specific number of steps and milestones that must be attained.

是的。這是一個很好的問題，坦白說，這是最重要的問題之一，因為它對所有利害關係人的機會至關重要。正如您所描述的，特別是 Avance 以及整個演算法值得成為護理標準。但任何醫療保健產品的護理標準都有必須達到的特定步驟和里程碑。

And the opportunity for the business going forward is to work on those. And specifically, these involve evidence, collaboration with the societies and the stakeholders who treat these particular patients, the endorsement of that and ensuring that you meet the requirements that allow for classification as an expected solution as opposed to just an option, and then, finally, coordination with payers.

企業未來的機會就是致力於這些。具體來說，這些涉及證據、與治療這些特定患者的協會和利益相關者的合作、對此的認可並確保滿足允許分類為預期解決方案而不只是一種選擇的要求，然後，最後，與付款人協調。

And so these are processes that typically take no less than three years and, more often, closer to 5 years. And when you look at the various applications for our products, specific plans need to be developed and pursued to achieve those because there is no one single standard of care that will come with a product like Avance or the algorithm because it will be different for breast neurotization than it will be for prostate, than it will be for head and neck or OMF. And that is one of the opportunities that I observed during my original diligence about Axogen and believe can be achieved.

因此，這些過程通常需要不少於三年的時間，更常見的是接近五年的時間。當您查看我們產品的各種應用時，需要製定並實施具體計劃來實現這些目標，因為像 Avance 或演算法這樣的產品不存在單一的護理標準，因為乳房的情況會有所不同神經化程度高於前列腺、頭頸部或OMF。這是我在最初對 Axogen 的調查中觀察到的機會之一，並相信這是可以實現的。

There's tremendous goodwill amongst the customers who treat these patients. The employees have a tremendous institutional knowledge upon which to build upon. And I think we can achieve these things for the simple reason that standard of care for any product is ultimately determined by relative benefit versus risk.

治療這些患者的顧客之間有著巨大的善意。員工擁有豐富的機構知識可供參考。我認為我們能夠實現這些目標的原因很簡單，任何產品的護理標準最終都是由相對效益與風險決定的。

And the products that Axogen has built over the many years more than justify that status because from a safety signal standpoint, there is literally 0 risk that you're asking a patient to accept as part of the use of one of these products.

Axogen 多年來開發的產品不僅證明了這一地位，因為從安全訊號的角度來看，您要求患者接受使用其中一種產品的風險實際上為零。

And as for the question as to whether or not there is efficacious benefit, the evidence is more than sufficient to justify that. As compared to the alternatives, there really is no better solution than the prescription of Avance and/or part of the algorithm for these.

至於是否有功效的問題，證據就已經足夠了。與替代方案相比，確實沒有比 Avance 的處方和/或部分演算法更好的解決方案了。

So that's why I'm here. I'm very excited about the future. However, those are the mechanics that I referred to. I understand how that game is played. And frankly, we're all pretty excited to play that game going forward.

這就是我來這裡的原因。我對未來感到非常興奮。然而，這些是我提到的機制。我明白這個遊戲是怎麼玩的。坦白說，我們都非常興奮能夠繼續玩這款遊戲。

Michael Sarcone with Jefferies.

邁克爾·薩爾科內和杰弗里斯。

Mike, congrats on the new position. So just to follow up a little bit on Chris' question, understanding we're going to get some more detail in early 2025, Mike, I just wanted to get your take. I agree that the strategy to focus on the primary accounts and deepening penetration there has been great.

麥克，恭喜你獲得新職位。因此，為了跟進 Chris 的問題，我們將在 2025 年初獲得更多詳細信息，Mike，我只是想聽聽您的看法。我同意專注於主要客戶並深化滲透的策略非常棒。

But when you look kind of mid- to longer term about the sustainability of growth in the business, like how -- I guess, how far does deepening penetration in those primary accounts get you to sustain growth versus, at some point, needing to expand beyond just those primary accounts into maybe a broader customer set?

但是，當你從中長期來看業務成長的可持續性時，比如我猜，加深對這些主要客戶的滲透能在多大程度上讓你維持成長，而不是在某個時候需要擴張除了這些主要客戶之外，也許還有更廣泛的客戶群？

Sure. I'll speak generally. And as I mentioned, when we get together again in the new year, we're going to go into specifics. We totally understand and respect that each all of our stakeholders need to understand why we're focusing where we focus, and that means there needs to be objective criteria to share with you, and so we fully intend to do that.

當然。我就籠統地講一下。正如我所提到的，當我們在新的一年再次聚在一起時，我們將討論具體細節。我們完全理解並尊重我們的每位利害關係人需要理解為什麼我們專注於我們關注的領域，這意味著需要有客觀的標準與您分享，所以我們完全打算這樣做。

But if I were to speak generally, when you just look at the world of trauma, whether it be a transected or non-transected situation, there's more than 1 million of these incidents per year that, ideally, should be addressed. So then you then look at where we actually stand in terms of penetrating or fully exploiting these, well, those who know us have high respect for what we do.

但如果我籠統地說，當你看看創傷世界時，無論是橫斷的還是非橫斷的情況，每年都會有超過 100 萬起此類事件，理想情況下應該得到解決。然後你看看我們在滲透或充分利用這些方面的實際立場，嗯，那些了解我們的人對我們所做的事情非常尊重。

The reality is that this therapy -- these therapies are very immature in terms of market development. There's much to do. There's many people who still don't know who Axogen or Avance is. And there's others who are interested, but it is only part of their current routine. Hence, a lack of confidence.

現實情況是，這種療法——這些療法在市場發展方面非常不成熟。有很多事情要做。很多人仍然不知道 Axogen 或 Avance 是誰。還有其他人感興趣，但這只是他們目前例行公事的一部分。因此，缺乏信心。

And when you look at all the potential sites that could participate in nerve repair or intervention, it's a very large universe, begging the question what are the business models necessary to prosecute those. And so that's what we're working on.

當你查看所有可以參與神經修復或介入的潛在站點時，你會發現這是一個非常大的宇宙，引出了一個問題：執行這些站點所需的商業模式是什麼。這就是我們正在努力的方向。

There's no shortage of opportunity, but you need to stand back and say, "Okay, where are we going to go first? And how are we going to do that? And that's what we're working on. And we believe we have line of sight to how better to do that.

機會不缺乏，但你需要退後一步說：「好吧，我們先去哪裡？我們要怎麼做呢？這就是我們正在努力的方向。我們相信我們有能力更好地做到這一點。

Obviously, we have a historical platform built around trauma. Even trauma has optimizations in the business model that we think we can pursue. And that's what we'll be talking about in the new year.

顯然，我們有一個圍繞創傷建立的歷史平台。即使是創傷，也可以優化我們認為可以追求的商業模式。這就是我們在新的一年要討論的內容。

But I'm not all concerned about the ability to sustain growth, so long as we focus on the basics on asking the questions and answering them properly relative to what are the normal requirements for standard of care and what is the business model necessary to deal with a particular area because, again, there's many different applications for our products, different customers, and they will require different business models to support that.

但我並不完全關心維持成長的能力，只要我們專注於提出問題並正確回答問題的基礎知識，相對於護理標準的正常要求是什麼以及處理問題所需的商業模式是什麼對於特定領域，因為我們的產品有許多不同的應用程序，不同的客戶，他們將需要不同的業務模型來支援。

Understood. That's really helpful. And maybe just one for Nir, again, on the guide. Appreciate that there's some level of conservatism there. I was wondering if you could talk, Nir, about what would the underlying assumptions or environment need to be to kind of hit the low end of that 4Q implied guide versus the high end.

明白了。這真的很有幫助。也許只是尼爾的一個，再一次，在指南上。認識到那裡存在一定程度的保守主義。Nir，我想知道您是否可以談談要達到第四季度隱含指南的低端與高端，需要什麼基本假設或環境。

Yes. So I think that, as Mike mentioned before, we really wanted to come with a guidance that we feel absolutely confident with. I think that we're, as we mentioned, very optimistic towards going into the new year.

是的。所以我認為，正如麥克之前提到的，我們真的希望提供一個我們絕對有信心的指導。正如我們所提到的，我認為我們對進入新的一年非常樂觀。

That said, there could be some interruptions, say, following the hurricanes with respect to supply chain that could take our revenue and revenue of other companies down. This is what is potentially implied with the lower range.

也就是說，供應鏈可能會出現一些中斷，例如颶風之後，這可能會導致我們和其他公司的收入下降。這就是較低範圍可能暗示的內容。

Caitlin Cronin with Canaccord Genuity.

凱特琳·克羅寧 (Caitlin Cronin) 與 Canaccord Genuity。

Congrats on a great quarter. So just to start with the BLA and the standard review, why did the FDA accept your request for priority review? And what's the significance of the FDA not holding an Advisory Committee meeting?

恭喜您度過了一個出色的季度。那麼首先從 BLA 和標準審查開始，為什麼 FDA 接受您的優先審查請求？FDA不召開諮詢委員會會議有何意義？

I would speculate -- the way to answer your question, I have to speculate, we see nothing untoward in terms of that decision. We're very pleased with the fact that they've identified that the submission is ready for review. That's essentially what they've told us.

我會推測——回答你的問題的方式，我必須推測，我們認為這個決定沒有什麼不妥之處。我們非常高興他們確定提交的內容已準備好接受審核。這基本上就是他們告訴我們的。

As for whether it was priority or standard, I can't speak to that. To be honest, I don't know. And I could speculate positively and negatively and that -- but that would all be -- they don't -- when we had these conversations, we don't get into discussions with the regulators about that. It's just that -- that's what they came back with.

至於是優先還是標準，我不好說。老實說，我不知道。我可以做出積極和消極的推測——但這一切都是——他們不會——當我們進行這些對話時，我們不會與監管機構就此進行討論。只是——這就是他們回來的結果。

And as for whether or not -- as to why they've decided not to have an Advisory Committee, again, I wouldn't want to speculate on their behalf. But I think when you look at the history of the product, when you look at its safety profile and the relevant evidence, what I want to believe is that they see this as efficacious just as our customers and users do, and that while we need to go through this process, there's confidence in terms of the approval.

至於是否——以及為什麼他們決定不設立諮詢委員會，我不想代表他們猜測。但我認為，當你查看該產品的歷史，當你查看其安全概況和相關證據時，我想相信的是，他們認為這與我們的客戶和用戶一樣有效，而且雖然我們需要完成這個過程，獲得批准就有信心。

Great. And then I didn't see this in the press release, but will you be reporting on core accounts and direct reps going forward?

偉大的。然後我在新聞稿中沒有看到這一點，但是您會報告未來的核心客戶和直接代表嗎？

We will not, not in near term. We mentioned high potential accounts. I think core accounts, I can't really speak to the past. But really, almost one year ago now, Doris, the leader of sales and Jens, our leader of global marketing, identifies a very basic application of focus in the trauma business, in particular, that asked everyone to focus on where we already have depth and experience and volume that would allow us to build from.

我們不會，短期內不會。我們提到了高潛力客戶。我認為核心帳戶，我無法真正談論過去。但實際上，大約一年前，銷售領導者 Doris 和我們的全球行銷領導者 Jens 確定了聚焦在創傷業務中的一個非常基本的應用，特別是要求每個人都關注我們已經有深度的領域以及讓我們能夠繼續建構的經驗和數量。

One of the really big -- one of the most important opportunities for trauma going forward is to make a standard of care within an institution the treatment of nerve. There's a lot of nerve opportunity across the country and, in fact, in every marketplace. So you can go to this hospital or go to that hospital, and you can do a procedure.

未來創傷治療中最重要的機會之一是在機構內制定神經治療護理標準。全國各地，事實上，每個市場都有很多令人興奮的機會。所以你可以去這個醫院或是去那個醫院，都可以做一個手術。

But institutionally, what the team is trying to do is to focus on specific accounts, build upon history and build upon volume potential in already trained microsurgeons and to make within that institution the expectation that treating the nerve is standard of care for them.

但從制度上講，該團隊試圖做的是專注於特定的情況，以歷史為基礎，以已經受過訓練的顯微外科醫生的數量潛力為基礎，並在該機構內建立這樣的期望：治療神經是他們的護理標準。

And so that's why we're focusing on high potential, and it's not really new. They've been working on this for a while. It's just beginning to show some fruits. And our initial inspection is that it is and that we're going to continue with that.

這就是我們關注高潛力的原因，這並不是什麼新鮮事。他們已經為此努力了一段時間。它剛開始結出一些果實。我們的初步檢查結果是確實如此，我們將繼續這樣做。

Mike Kratky with Leerink Partners.

邁克·克拉基 (Mike Kratky) 與 Leerink Partners 合作。

Congrats on the great quarter. Mike, great to have you on board. Maybe a high level, Mike, I'd love to hear how you're thinking about what the potential BLA approval next September could mean from a commercial standpoint for Avance.

恭喜這個偉大的季度。麥克，很高興你加入。也許是高層，麥克，我很想聽聽您如何看待明年 9 月 BLA 的潛在批准從商業角度對 Avance 意味著什麼。

How much of a game changer do you expect this to be? And based on what you've learned so far, how do you expect this to change the treatment patterns for this product or how it's perceived by patients, physicians or hospitals probably?

您認為這會在多大程度上改變遊戲規則？根據您迄今為止所了解的情況，您預計這會如何改變該產品的治療模式，或者患者、醫生或醫院可能如何看待它？

Certainly. I think it's very important, and I don't know how everyone is viewing it. I'll just share with you how I and the team view it. And specifically, while we have approval to market today, it's by design a temporary status. And it was all part of a process to expect us to move and qualify the product under the new guidelines.

當然。我覺得非常重要，不知道大家怎麼看。我只是與大家分享我和團隊的看法。具體來說，雖然我們今天已獲准上市，但這只是一個臨時狀態。這都是期望我們根據新指南移動和鑑定產品的過程的一部分。

And so while that does allow us freedom to operate, there's always the question marked around the actual status of the product for some folks and then payers, in particular. So from a payer's viewpoint, if they know nothing about this and they were just to go through their normal checkoff process, the product can appear to them from a status standpoint as experimental.

因此，雖然這確實允許我們自由操作，但對於某些人，尤其是付款人來說，產品的實際狀態始終存在問題。因此，從付款人的角度來看，如果他們對此一無所知，並且只是完成正常的檢查流程，那麼從狀態的角度來看，該產品對他們來說可能是實驗性的。

So the bottom line is establishing this with -- and gaining the final approval through the BLA process is important strategically because it affirms that, number one, this is a first in its class. It has been accepted as both safe and effective based upon these expectations with no qualifiers necessary, and then with that allows us to move forward on these market development efforts pursuing standard of care.

因此，最重要的是透過 BLA 流程獲得最終批准具有重要的戰略意義，因為它首先確認這是同類產品中的首例。基於這些期望，它被認為既安全又有效，無需任何限定條件，這樣我們就可以繼續推進這些追求護理標準的市場開發工作。

Standard of care requires these formal approvals. It requires consensus guidelines amongst the societies, requires a further accumulation of evidence. And so BLA is important strategically insofar as it enables all of those things that I just described. So hopefully, that answers most of your question.

標準護理需要這些正式批准。它需要社會間達成共識的指導方針，需要進一步累積證據。因此，BLA 在戰略上非常重要，因為它能夠實現我剛才描述的所有這些事情。希望這能回答您的大部分問題。

Yes, super helpful. And maybe just one follow-up. One thing I don't know -- I heard as much about on the call is just how you're exploring business development opportunities. As you're scaling up the adjusted EBITDA, is that something that you're going to be ultimately looking at in terms of broadening your portfolio?

是的，超級有幫助。也許只是一個後續行動。我不知道的一件事是——我在電話會議上聽到的很多內容就是你們如何探索業務發展機會。當您擴大調整後的 EBITDA 時，您最終會考慮擴大投資組合嗎？

Yes. Well, bottom line, our mission is what described is standard of care status. And so anything that would be necessary to facilitate that would be within scope. I'm not trying to be coy, and just there is no specific target per se. It's what would be required within this space or that space to achieve that. And based upon what that is, we would consider that within scope.

是的。嗯，最重要的是，我們的使命就是所描述的護理狀態標準。因此，促進這一目標所需的一切都在範圍之內。我並不是想含糊其辭，只是本身沒有具體的目標。這是在這個空間或那個空間內實現這一目標所需要的。基於這一點，我們會認為它在範圍內。

So whether that be internal or external, all things are always on the table because it's about winning at the end of the day on behalf of the patient. If we do that, shareholders benefit as well. But I'm not trying to telegraph that there's anything in the way. I'm just saying with -- as we look to the future, it's about how to most solidly and completely attain that status.

因此，無論是內部還是外部，所有事情都始終擺在桌面上，因為這關係到最終代表患者取得勝利。如果我們這樣做，股東也會受益。但我並不是想表明有什麼問題。我只是說，當我們展望未來時，問題是如何最紮實、最徹底地達到這種地位。

Jayson Bedford with Raymond James.

傑森貝德福德和雷蒙德詹姆斯。

Congrats on the progress here. Just maybe a couple. Avive+, can you talk about the launch, the uptake and whether it was a notable contributor in 3Q?

恭喜這裡的進展。也許只是一對。Avive+，您能談談它的發布、使用情況以及它是否在第三季度做出了顯著的貢獻嗎？

Yes. Avive+ has progressed well. We are moving through the manufacturing process, so we can make it more fully available. We've made good progress on that.

是的。Avive+ 進展順利。我們正在完成製造過程，因此我們可以使其更全面地可用。我們在這方面已經取得了良好進展。

And relative to, again, the whole algorithm, it's important for the business because for certain applications where temporary healing process is what's the focus of the surgeon, Avive+ fulfills that gap more completely as opposed to some of our other solutions. And to that end, it's been received very favorably.

再次，相對於整個演算法，這對於業務來說很重要，因為對於某些應用程式來說，臨時癒合過程是外科醫生關注的重點，與我們的其他一些解決方案相比，Avive+ 更完全地填補了這一空白。為此，它受到了非常熱烈的歡迎。

In terms of actual significance, in terms of the results, it's all obviously on a relative basis. And we can discuss more of that in Q1. But the product is being received very well, particularly as we're starting to be able to make it fully available from a supply standpoint.

從實際意義來看，從結果來看，顯然都是相對的。我們可以在第一季討論更多內容。但該產品的反應非常好，特別是當我們開始能夠從供應的角度完全提供它時。

Okay. Just maybe on that, I thought the gross margin number was also a highlight, looking to be more efficient here from the APC facility. I think the full year guidance implies this.

好的。也許就這一點而言，我認為毛利率數字也是一個亮點，希望 APC 設施的效率更高。我認為全年指引暗示了這一點。

But is the expectation that we trend higher on gross margin from here? And just out of curiosity, is there any way you can kind of frame the level of Avance product coming from this facility now?

但我們的毛利率是否會從此開始走高？出於好奇，有什麼方法可以確定現在來自該工廠的 Avance 產品的水平嗎？

Yes. So for the year, as we mentioned, we expect to be at the high end of the annual margin guidance. And also as we mentioned in the last quarter that we expected the last quarter's margin to be at or close to the bottom of the trough. This has been the case.

是的。因此，正如我們所提到的，今年我們預計將達到年度利潤率指引的高端。正如我們在上個季度提到的，我們預計上個季度的利潤率將達到或接近谷底。情況就是如此。

Going forward, as we mentioned in the past, the trend of the gross margin is probably a function of the two trends. One, taking it down, the higher proportion of products that we're selling that were manufactured at the APC, the new plant at a higher cost. On the other hand, you have a process and efficiency improvements and a higher capacity utilization, which takes the margin up, which we believe will be the prevalent trend, absent of any product mixes going forward into the future.

展望未來，正如我們過去所提到的，毛利率的趨勢可能是這兩個趨勢的函數。第一，在我們銷售的產品中，在 APC（新工廠）生產的產品比例更高，成本更高。另一方面，流程和效率的改進以及更高的產能利用率，這會提高利潤，我們相信這將是普遍趨勢，未來沒有任何產品組合。

Ross Osborn with Cantor Fitzgerald.

羅斯·奧斯本與康托·菲茨杰拉德。

Congrats on the progress. And Mike, welcome aboard. So following up on a previously asked question, but maybe I'll go at it in a different manner. Curious to your thoughts on the company's strategic focus in terms of driving growth versus cash as you seek to become standard of care.

祝賀取得的進展。麥克，歡迎加入。因此，跟進之前提出的問題，但也許我會以不同的方式來解決它。當您尋求成為護理標準時，很好奇您對公司在推動成長與現金方面的策略重點的看法。

I don't know that the two are mutually exclusive, but that's what we'll be able to describe in a more material way in Q1. So the business is making good forward progress, as Nir described in that regard. And we're laying out what those time lines would be in the various business models, so that we can understand that more completely. But simply said, I don't know that they're mutually exclusive.

我不知道這兩者是相互排斥的，但這就是我們將能夠在第一季以更具體的方式描述的。因此，正如尼爾在這方面所描述的那樣，該業務正在取得良好的進展。我們正在列出各種商業模式中的時間線，以便我們能夠更全面地理解。但簡單地說，我不知道它們是互相排斥的。

Okay. Fair enough. And then, I guess, lastly for us, could you provide some more color on your initiatives in breast neurotization such as the National Resensation Breast Program?

好的。很公平。然後，我想，最後對我們來說，您能否為您在乳房神經化方面的舉措提供更多的信息，例如國家乳房感覺恢復計劃？

Sure. So this is still a relatively small team, but it enjoys a very high growth. Again, we'll describe the details in the future. What we can share with you from a qualitative standpoint is that the interest in learning how to do these types of procedures with the different ways to conduct breast reconstruction is extremely high.

當然。所以這仍然是一個相對較小的團隊，但它享有非常高的成長。同樣，我們將在以後描述詳細資訊。從定性的角度來看，我們可以與您分享的是，人們對學習如何使用不同方法進行這些類型的乳房重建手術的興趣非常高。

It's considered the right thing to do, and it's considered a necessary skill set to be able to do this. And so when we hold our educational programs, we have very strong demand. And I've had -- really upon my arrival, I had a chance to attend one of these. And I believe that I can look back in my career and say that I know what good looks like from an educational standpoint.

這被認為是正確的做法，並且被認為是能夠做到這一點的必要技能。所以當我們舉辦教育計畫時，我們有非常強烈的需求。事實上，在我到達之後，我就有機會參加其中的一場活動。我相信，當我回顧自己的職業生涯時，我可以說，從教育的角度來看，我知道什麼是好的。

And honestly, Axogen's, the quality of their program, the discussions, the actual practical hands-on is some of the best work that I've ever had experienced to be a part of.

老實說，Axogen 的專案品質、討論和實際操作是我參與過的最好的工作之一。

And so they do a really good job. And you talked about products, you talked about technology and what's proprietary and unique. I would say Axogen's ability to conduct education in these novel areas is one of their distinctive assets.

所以他們做得非常好。您談到了產品、技術以及專有和獨特的東西。我認為 Axogen 在這些新穎領域開展教育的能力是其獨特的資產之一。

So hopefully, that answers your question, but there's no shortage of interest in breast neurotization. The feedback, I've had a chance to talk to patients, I talk to physicians who are doing these procedures, they believe in this, and there is a very strong future for breast neurotization.

希望這能回答你的問題，但人們對乳房神經化並不缺乏興趣。回饋，我有機會與患者交談，我與正在進行這些手術的醫生交談，他們相信這一點，乳房神經化有一個非常光明的未來。

Dave Turkaly with Citizens JMP.

Dave Turkaly 與 Citizens JMP。

Congrats, Mike. Given your background and some of the experience you've had, and this is sort of a newer arena for a lot of folks, but I'd just sort of like to ask and appreciate the comments you made upfront, but what's been the biggest surprise since you joined?

恭喜，麥克。考慮到你的背景和你所擁有的一些經驗，這對很多人來說是一個較新的舞台，但我只是想詢問並欣賞你預先發表的評論，但最大的評論是什麼加入後有驚喜嗎？

Great question. As you can tell, I'm trying to figure out. How would I have an answer?

很好的問題。正如你所知，我正在努力弄清楚。我怎樣才能得到答案？

I'll let you think about that, and I'll ask you a second one if you want.

我會讓你考慮一下，如果你願意的話，我會問你第二個問題。

No, no, no. I think the surprise is, I don't know if it surprise is the right word, just recognition that chronological age aside, market development is still early with every single possible application in terms of the work that you -- that needs to be done in order to take advantage of something as unique as Axogen. So I think, again, I don't know if surprise would be the right word, just more recognition.

不，不，不。我認為令人驚訝的是，我不知道“驚訝”這個詞是否正確，只是認識到除了時間年齡之外，市場開發還處於早期階段，就您需要完成的工作而言，每一個可能的應用程序為了利用像Axogen 這樣獨特的東西。所以我再次認為，我不知道「驚訝」這個詞是否合適，只是更多的認可。

Great. And then in your commentary, I heard you say prostate and I've followed the company for a long time. I've not really heard that talked about a lot, and I know they probably expand in on the 4Q call. But just high level, could you explain exactly what that kind of opportunity might look like?

偉大的。然後在你的評論中，我聽到你說前列腺，我已經關注該公司很久了。我並沒有真正聽到很多討論，而且我知道他們可能會在 4Q 電話會議上擴展。但就高水準而言，您能否準確地解釋一下這種機會可能會是什麼樣子？

We're not necessarily specific to prostate, but maybe just kind of lay it out. Trauma, by definition of the word, implies that you have an emergent situation, which is significant, and that nerve has been transected or contused in such a way that -- but it's also part of a lot of other things going on at the same time.

我們不一定專門針對前列腺，但也許只是簡單地闡述一下。創傷，根據這個詞的定義，意味著你遇到了緊急情況，這很重要，神經被橫斷或挫傷，但它也是同時發生的許多其他事情的一部分時間。

So these are not the easiest procedures upon which to intervene. Yet that's, of course, where we were founded because that's where the greatest need was. But when you look at any other situation where nerve is impacted, that's elective. You have a more controlled situation. You have the ability to plan for it. You're not dealing most often with collateral damage that also may affect the actual outcome.

因此，這些並不是最容易介入的程序。當然，這就是我們成立的地方，因為那是最需要的地方。但當你看到任何其他影響神經的情況時，你會發現這是選擇性的。你的情況更加可控。你有能力為此做好計劃。您不會經常處理也可能影響實際結果的附帶損害。

So in that sense, the -- Avance has the potential to work more simply and with even higher efficacy and almost anything that's outside of trauma simply because you don't have those other attendant elements to deal with.

因此，從這個意義上說，Avance 有潛力更簡單地工作，甚至具有更高的功效，並且幾乎可以處理任何創傷之外的事情，因為您沒有其他伴隨因素需要處理。

So again, I'm generalizing, but that's one of the things that I think holds a great opportunity is when we start to expand the offering into these other areas because the product is going to work -- has a chance to work even better, not less in those types of situations.

再次強調，我正在概括，但我認為擁有絕佳機會的事情之一是，當我們開始將產品擴展到其他領域時，因為該產品將會發揮作用 - 有機會發揮得更好，在這些類型的情況下不少於。

Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Mr. Dale for any final comments.

女士們先生們，我們的問答環節到此結束。我將把最後的意見轉回給戴爾先生。

Thank you, operator. On behalf of the Axogen team, I want to thank everyone for their time and interest in our work to fulfill the promise and potential for all stakeholders in our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function and expected standard of care.

謝謝你，接線生。我謹代表 Axogen 團隊感謝大家花時間和對我們工作的興趣，以實現我們業務目標中所有利益相關者的承諾和潛力，即通過恢復周圍神經功能和預期來恢復健康和提高生活質量。

We look forward to updating you on our continued progress and our plans for the future next quarter. Thank you.

我們期待向您通報我們的持續進展以及下一季的計劃。謝謝。

This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。